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ETC / RX - Systemic anti-infective agents - OpeAzitro 100, 200

COMPOSITION:

Azithromycin: 100 mg, 200 mg
Per each film coated tablet.


INDICATIONS:

Azithromycin is indicated for infections caused by susceptible organisms, such as:

  • Lower respiratory tract infections: Community-acquired pneumonia, bronchitis.
  • Upper respiratory tract infections: Pharyngitis, tonsillitis, sinusitis and otitis media
  • Skin and soft tissue infections
  • Uncomplicated genital infections due to Chlamydia trachomatis.

ADMINISTRATION AND DOSAGE:

Azithromycin should be taken at least 1 hour before or 2 hours after meals.
Azithromycin should be administered according to 3-day regimen or 5-day regimen:
3-day regimen:
The recommended dose in children is 10 mg/kg as a single daily dose for 3 days. The total dose is 30mg/kg.

Doctors also recommend the single daily dose for 3 days by age and weight as follows:

Age

Weight

Single daily dose

6 months-3 years

8-15 kg

10 mg/kg

3-7 years

15-25 kg

200 mg

8-11 years

26-35 kg

300 mg

12-14 years

36-45 kg

400 mg

Efficacy and safety information in children under 6 months of age is lacking, so the use of drugs is not recommended in this age group.
5-day regimen:
The recommended dose in children is 10 mg/kg as a single dose on the first day, followed by 5 mg/kg on day 2 through day 5 of the regimen.


CONTRAINDICATIONS:

Patients with known hypersensitivity to the ingredients of product or to any of the macrolide antibiotics.


WARNINGS AND PRECAUTIONS:

  • Since there is a risk of superinfection with non-susceptible bacteria and risk of pseudomembranous colitis while using any broad spectrum antibiotics, caution should be exercised while using azithromycin.
  • Serious allergic reactions, such as angioedema and anaphylaxis have been reported rarely in patients on azithromycin and other macrolide therapies.
  • Renal impairment: No dose adjustment is needed in patients with mild renal failure (creatinine clearance > 40 mL/min). However, as no data is available regarding the use of azithromycin in patients with more severe renal impairment, caution should be exercised while using the drug in these patients.
  • Hepatic impairment: As the hepato-biliary system is the principal route of excretion of azithromycin, it should not be used in patients with hepatic impairment.
  • Pregnancy and lactation: Azithromycin should not be used during pregnancy and lactation, unless absolutely needed.
  • Azithromycin is not expected to affect your ability to drive or operate machinery.

SIDE EFFECTS:

Azithromycin is a well tolerated drug. Some side effects may be nausea, vomiting, flatulence diarrhea, skin rash and pruritus. Occasionally, reversible elevations in liver transaminases can be seen similar to other macrolides


INTERACTIONS:

  • Antacids reduce the absorption of azithromycin, so when co-administrated it should be taken 1 hour before or 2 hours after the antacid administration. .
  • Because of potential interaction between azithromycin and cyclosporin, cyclosporin levels should be monitored and the dose should be adjusted if co-administration is necessary.
  • Some of the macrolide antibiotics are known to decrease the biotransformation of digoxin. Although there is no report regarding such an effect with the use of azithromycin, the possibility of an interaction with concomitant use should be borne in mind and digoxin levels should be monitored.
  • As with other macrolide antibiotics, azithromycin should not be co-administered with ergot derivatives.

PRESENTATION:

  • Box of 6 sachets x 2.5 g oral powder
  • Box of 3 sachets x 2.5 g oral powder
  • Box of 1 blister x 6 film coated caplets.

Box of 1 blister x 3 film coated caplets